Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy

Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy

To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Inclusion Criteria:

• Histologically confirmed invasive breast cancer;
• Post-surgery, primary lesion been removed;
• Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
• Histologically confirmed ER and/or PR positive ;
• Receiving adjuvant AIs therapy in the following one years;
• Leukocyte ≥ 3*10(9)/L; Platelets ≥ 75*10(9)/L;
• Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal range;
• Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
• Written informed consent according to the local ethics committee equirements;

Exclusion Criteria:

• Metastatic Breast Cancer;
• Received Neo-Adjuvant Endocrine Therapy;
• History of pelvic fracture or bone metabolic disease;
• Received drugs interfering bone metabolism in the last 12 months;
• Baseline Bone Mineral Density: T < -2SD;
• With other primary malignant disease;
• With severe non-malignant co-morbidity that will influence long-term follow up;
• Known severe hypersensitivity to any drugs in this study;